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Job Details

Start Up Officer

Company: Chiltern
Location: Lisbon
Reference: SU - PT
Closing Date: 21 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern is looking to recruit a Start Up Officer office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company.

Requirements:

Job Background

Chiltern is the leading, global mid-sized contract research organization. We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services.  Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.

Chiltern is looking to recruit a Start Up Officer office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company.

The Clinical Trials Application (CTA) Officer function is part of the local Regulatory Affairs team reporting to the local Head of Regulatory Affairs and maintains close functional relations with the Clinical Operations team.

The CTA Officer is responsible to:

  • perform correct and timely submissions of Clinical Trial Applications (CTA’s) to the competent authority and ethical committees to ensure that the clinical studies starts in time.
  • collect the essential documents and prepare the applicable forms for submissions, in close collaboration with the CML/CRA responsible persons.
  • keep tracking of all submitted CTA’s and substantial amendments and to update applicable databases
  • act as the contact person for both Regulatory Authorities and sponsors functions with regard to CTA’s and related information.
  • keep tracking about applicable laws and regulations related to the submission of clinical trial and maintain the internal Clinical Operations functions properly informed.
  • train other colleagues on processes of submission of clinical trials, whenever applicable.

Requirements:

  • Scientific degree in the area of health sciences
  • At least 2 years of experience in a similar role, preferably with experience in RNEC Platform Submissions
  • In-depth knowledge of pharmaceuticals and of local and international clinical trial regulations
  • Fluency (oral and written) in both Portuguese and English language
  • Effective communication, organizational, and planning skills
  • Ability to work independently and to effectively prioritize tasks
  • High attention to detail and accuracy


Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On application

Position Type

Permanent
Full Time

Contact

Email Kevin Thomas - kevin.thomas@chiltern.com
+33 01 41 05 73 53

Apply for this job: Start Up Officer

Contact Information:

Address:  France
37 bis rue de Villiers, 92200 Neuilly sur Seine, France

France
Tel:  +33 1 41 05 73 00
Fax:  +33 1 41 05 73 01
Website:  Visit Our Web Site

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